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Skin Relief Cream hydrocortisone .45 mg/45mL Lotion, 30 mL — NDC 68062-2266-01 package photo

Skin Relief Cream hydrocortisone .45 mg/45mL Lotion, 30 mL

by Spa de Soleil · 30 mL in 1 TUBE (68062-2266-1)
NDC 68062-2266-01
🏷️ FDA NDC (as labeled) 68062-2266-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 68062-2266-1
Product NDC 68062-2266
11-digit billing NDC 68062226601
UNII WI4X0X7BPJ
Application # M016
SPL Set ID 0a90b77a-4be4-71c5-e063-6294a90a8e41
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-19
Route TOPICAL
Dosage form LOTION
Substance HYDROCORTISONE
Why two NDCs? The FDA registers this code as 68062-2266-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 68062-2266-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerSpa de Soleil
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code68062
First marketedNov 2023
Product typeHuman Otc Drug
Portfolio35 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's designed to calm down inflammation — so the redness, swelling, and itching that come with conditions like eczema should ease up, usually within a few days of consistent use. I...
  • What exactly is this cream supposed to do for my skin?
  • That's a really important question. Hydrocortisone is generally meant for short courses — typically a few weeks. Long-term or widespread use can cause side effects like skin thinni...
  • How long can I keep using it? Is it okay to use every day long-term?
📖 Read our full Hydrocortisone guide →
8
Nutrient depletion considerations

Hydrocortisone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Hydrocortisone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesWater, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Glycerin, Dimethicone, Propylene Glycol, Cetyl Alcohol, Sorbitol, Carthamus Tinctorius (Safflower) Seed Oil, **Squalane, Carbomer, Lactic Acid, Peg-4, Morus Alba Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Kojic Acid, Butylene Glycol, Arctostaphylos Uva-Ursi Leaf Extract, Sodium Hydroxide, Ruscus Aculeatus Root Extract, Ginkgo Biloba Leaf Extract, Diospyros Kaki Fruit Extract, Betula Alba Bark Extract, DMAE, Thioctic Acid, Ubiquinone, *CO Glycerin, Citric Acid, Malic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Malus Domestica Fruit Cell Culture Extract, Glycolic Acid, Salicylic Acid, Tartaric Acid, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Xanthan Gum, Lecithin, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Dehydroacetic Acid

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Skin Relief Cream .45 mg/45mLthis 68062-2266-01 Spa 30 ml — — FDA listed —
Dr Lift Soothing Cream .45 mg/45mL 68062-2264-01 Spa 45 ml — — Discontinued —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Hydrocortisone (matched by generic name) — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Hydrocortisone. CMS lists 11 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.92M
Claims incl. refills
699.9K
Beneficiaries
529.9K
Spend / beneficiary
$37.60
Spend / claim
$28.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Skin Relief Cream (this brand).

Top reported reactions

Fatigue5,917
Condition Aggravated5,454
Nausea4,998
Rash4,907
Diarrhoea4,451
Headache4,425
Pain4,423

Age at onset

Neonate332
Infant314
Child1,040
Adolescent683
Adult7,947
Elderly3,424

Reporter sex

66,644 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization28,427
Death9,793
Life-threatening8,647
Disabling5,601
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 6,429 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68062-2266-01 You're viewing this 30 mL in 1 TUBE (68062-2266-1) 2023-11-19 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68062-2266-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68062-2266-01, written without dashes as 68062226601. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68062-2266-01, the first segment (68062) is the labeler code FDA assigned to Spa de Soleil; the middle segment (2266) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Spa de Soleil. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Spa de Soleil is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 12 words ▾

Uses: Protects skin from irritation and itching, promoting faster healing and renewal.

⏱️ Dosage and Administration 75 words ▾

Directions Directions • Clean the skin thoroughly before applying this product • Cover the entire affected area with a thin layer one to three times daily Directions(Continued) • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • If bothersome dryness or peeling occurs, reduce application to once a day or every other day

⚠️ Warnings 69 words ▾

Warnings For external use only. Avoid contact with the eyes If condition worsens or symptoms persist for more than seven days or clear up and occur again within a few days, stope use of this product and do not begin use of any hydrocortisone product until you have consulted a physician. Do not use for the treatment of diaper rash. Consult a physician. Keep out of reach of children.

🧪 Active Ingredient 4 words ▾

Active Ingredient Hydrocortisone 1%

🧪 Inactive Ingredients 152 words ▾

Inactive Ingredients: Water, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Glycerin, Dimethicone, Propylene Glycol, Cetyl Alcohol, Sorbitol, Carthamus Tinctorius (Safflower) Seed Oil, **Squalane, Carbomer, Lactic Acid, Peg-4, Morus Alba Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Kojic Acid, Butylene Glycol, Arctostaphylos Uva-Ursi Leaf Extract, Sodium Hydroxide, Ruscus Aculeatus Root Extract, Ginkgo Biloba Leaf Extract, Diospyros Kaki Fruit Extract, Betula Alba Bark Extract, DMAE, Thioctic Acid, Ubiquinone, *CO Glycerin, Citric Acid, Malic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Malus Domestica Fruit Cell Culture Extract, Glycolic Acid, Salicylic Acid, Tartaric Acid, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Xanthan Gum, Lecithin, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Dehydroacetic Acid

🎯 Purpose 2 words ▾

Purpose Anti-Inflammatory

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68062-2265-01 · Spa 68062-2267-01 · Spa →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.